Thursday, October 27, 2016

Agenda 2020 - Foresight, Not Hindsight

Agenda 2020 - Foresight, Not Hindsight

Re: The Institute for Health Research and the Vitamin Consultancy's Business Collaborative

The natural product industry in the United States has been growing rapidly for the past half century.  As a participant in that business, you want to know where it is going next. The next big thing? The next regulatory assault? You need foresight, not hindsight. That's what this private memo is about.

To paraphrase, "An industry divided will not stand."  I have been closely observing the direction the government is taking with regard to supplements and I don't like it! Back in the '70s and '80s there were far fewer supplement companies, and they were small by today's standards. But those that existed pulled together, understanding that there was safety in numbers, and by the mid-'90s we were able to cajole Congress into giving DSHEA (the Dietary Supplement Health and Education Act) unanimous approval.

The industry that grew from that push back is now maturing and its participants need to pay attention to the threats, and opportunities, on the horizon.

Since you are on my Vitamin Consultancy email list you probably know that I practiced law for 36 years, becoming known as The Vitamin Lawyer. Today I continue my work through my Vitamin Consultancy and as Vice President of Natural Solutions and President of the Institute for Health Research --

A plan is developing for the next few years that involves you and your company. The plan is called Agenda 2020 as it is envisioned to be fully implemented over the next four years -- our "20-20" vision for the future.

The plan includes continued enhancements to the Vitamin Consultancy, bringing additional professionals into the Consultancy. An example is the Cosmetic Dossier Service Dr. R. Goodman and I provide.

Our core VC services will continue to be upgraded:

1. Label, literature and claims consulting
2. General vitamin industry consulting
3. SOP and GMP compliance
4. The Cosmetic Dossier
5. The Vitamin Consultancy Webinar Training System
6. GMP physical and virtual audits

These services are funded through client fees and are self-supporting.

But that is not all that we do here. Natural Solutions Foundation and the Institute for Health Research have a significant portion of my attention, my time and advise. Their activities need to be self-supporting too. This memo focuses on the Institute.

But be aware there are some exciting changes coming to Natural Solutions -- to be covered in a future memo.

The Institute for Health Research was established in 1998 by Green Turtle Bay Vitamins founder Karen Horbatt and Dr. Richard Podell, a well-known Jersey physician and teacher. I am the third trustee. Today Ms Horbatt remains our Chairwoman Emeritus, I am President of the Institute and several health professionals, including Rima Laibow MD have joined the Board.

We have begun to publish a professional Journal and seek leading-edge health, natural approach research papers. Our focus is providing actionable information for people in the natural products arena. You can read the first published articles, by luminaries such as Gary Null, ND, Sharry Edwards, MEd and Rima Laibow, MD, at

US tax law allows your company to donate up to 5% of its gross profits to charitable activities, and gain a significant tax break. The Institute is authorized to accept such donations and issue the appropriate tax receipt. We have a PayPal donation button on the main page and are also happy to receive checks or money orders made out to the Institute c/o Ralph Fucetola, 58 Plotts Rd, Newton, NJ 07860.

How much of your company's gross profits are you ready to allocate toward protecting your Commercial Health Freedom? This is the time of year when it is prudent to make those allocations.

Here is the monthly Institute budget I need your help to meet:

1. Office space, overhead and supplies: $1500
2. Web Master / Site & Journal Maintenance: $1,000
3. EList maintenance: $700
4. Educate Decision Makers system: $700
5. Social Media Intern: $750

There are other expenses. For example, we need to develop a PR budget, including adequate funds for at least quarterly trips to venues such as Washington, DC or trade meetings.
Bottom line: what can funding the Institute office do for you?

The Vitamin Consultancy will be able to continue to provide you with a very high level of professional consulting for modest hourly fees, along with the Webinar System and other special services.

But, as the Institute becomes properly funded, in cooperation with the Consultancy, I will also be able to provide Sustaining Members early alerts critical to operating in an increasingly complex regulatory climate.

The first Alert from the Institute that I am preparing is a Special Report: Food Safety Regulation -- Action List. These will include summaries of the private alerts I provide  privately to my Monthly Retainer Consultancy Clients. Biannual registration renewals are due.

Another powerful business's tool we are developing is the Nutrient Companies' Business Collaborative -- a private information exchange that brings best practices to the fore, keeping the Sustaining Members at the leading edge.

The goal of the Collaborative is to introduce its members to each other, to share their special capacities for mutual benefit, and clout. "Push Back Works" and pushing back together works even better.

As a Sustaining Member your company will be among the first to hear about new technologies and leading edge approaches, such as using frequency in the testing and processing of food products. Here I am thinking of the pioneering frequency matrix work of Sharry Edwards or the recent frequency analysis article by Mike Adams.

How does your company become a Sustaining Member?

Set up a recurring donation through our PayPal donation button at or send a check or money order for one year (min. $1200). We will provide appropriate tax receipts. If it is convenient for you, I can arrange to have the Institute send you a monthly invoice from its PayPal account.

Whether a clear vision for Agenda 2020 comes into sight will depend on you seeing that vision benefiting the future success of your business. IMHO, it's time foresee where we are going.

Call me if you have any questions, or just to let me know that you are in...

Ralph Fucetola JD

Tuesday, October 18, 2016

Merchant Accounts for Nutrients

Merchant Account for Nutrients

One of the challenges facing dietary supplement companies is where to find merchant services, such as the ability to accept credit and debit cards for your product sales.  For leading-edge products this can be quite a challenge. For example, PayPal is well-known for cutting-off companies that sell products such as CBDs and the like.

Dan Fucetola of Winning Business Solutions has sourced a merchant account company that specializes in nutrient products.

You can find out more here:

Just click on "G.E.T. Merchant Account: START HERE."

"We are proud to partner with Global Electronic Technology, Inc. for Merchant Services. Yes, they do handle dietary supplement products and anything else you can sell. Start by sending us a message to the special contact form below. Our GET account manager Luis will contact you directly. Please include your phone and email."

Ralph ...
My experience will strengthen your company!  I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.          

Saturday, October 1, 2016

Vitamin Consultancy September 2016 Newsletter

Mail Chimp Version
CDC dangerous quarantine and treat/vax regulation
FDA offers 102 page NDI guidance
From: Ralph Fucetola JD

Welcome to the September 2016

Vitamin Consultancy eNewsletter.

The banner above, featuring yours truly and my co-trustees at Natural Solutions Foundation, Rima Laibow MD and Maj Gen Bert Stubblebine (US Army, Ret.) points to a very important and urgent matter.

The CDC has proposed a draconian quarantine and forced treatment/vaccination regulation, giving the public until October 19th to file comments. Under the Administrative Procedures Act, this is a necessary step for agency action, or for litigation testing the validity of the new rules. What does the rule say about Informed Consent? It says your consent "shall not be considered as a prerequisite..."

“§70.18 – Agreements. CDC may enter into an agreement with an individual, upon such terms as the CDC considers to be reasonably necessary, indicating that the individual consents to any of the public health measures authorized under this part, including quarantine, isolation, conditional release, medical examination, hospitalization, vaccination, and treatment; provided that the individual’s consent shall not be considered as a prerequisite to the exercise of any authority under this part.”

The FDA's guidelines for what is a New Dietary Ingredient (NDI) were issued in 2011. Last month an updating was proposed as FDA continues to implement a policy of making Dietary Supplement rules more like Pharmaceutical Rules rather than the food-standard regulation that Congress determined to be public policy in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The new document is 102 pages. The Devil, as they say, is in the Details. As is the deviltry...

This note is just to acquaint you with the fact that the rules are being made tougher. Bottom line: [1] what is an NDI and [2] how much harder will it be to have one approved by FDA?

[1] The definition, set by statute has not changed. The FDA now phrases it this way:

"On October 25, 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub.L. 103-417) was signed into law. DSHEA amended the FD&C Act by adding, among other provisions, (1) section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement”; and (2) section 413 (21 U.S.C. 350b), which defines the term “new dietary ingredient” and requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the product into interstate commerce or delivering it for introduction into interstate commerce, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. 350b(a)(1))."

[2] How much harder? That of course translates into, how expensive?

The more restrictions, the more expense. Being "grandfathered" and thus exempt from the NDI process is not easy, for example:

"A notification is not required when the NDI and all other dietary ingredients in the dietary supplement have been present in the food supply as articles used for food in a form in which the food has not been chemically altered. ... FDA interprets the phrase “present in the food supply” to refer to the conventional food supply. Accordingly, we interpret a dietary ingredient that has been “present in the food supply as an article used for food” to mean a conventional food or conventional food ingredient. We do not consider prior use in dietary supplements to constitute presence in the food supply."

More directly impacting cost is what are the requirements to prove the safety of the NDI?

"That standard provides that a dietary supplement containing the NDI is adulterated unless there is adequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury."

What evidence is sufficient to meet this standard?

"A notification should provide evidence of a history of safe use; other evidence of safety, including clinical testing, animal testing, or both; or some combination of history of use and other evidence of safety. The submitted data should provide the basis for a conclusion that there is a reasonable expectation of safety under the proposed conditions of use of the dietary supplement containing the NDI."

And, to the wise this interesting hint:
"FDA expects that when history of use evidence alone is adequate to support the safety of the NDI in the supplement, notifiers will prefer to use that route. Compared to the cost and time needed to conduct clinical or animal toxicology studies, it is generally less expensive and faster to gather historical information and to conduct chemistry studies to establish the identity of the historically used materials."

So, as your vitamin business moves ahead, you will need guidance in dealing with New Dietary Ingredients.

The Vitamin Consultancy is here to help with all aspects of new product development, from concept through testing, labeling, claim writing and the rest of your product presentation needs.
Standard Operating Procedures
Dietary Supplement and Natural Products
Development, Training & Deployment


...documentation of employee training is necessary

This web site, provides access to my Standard Operating Procedures certification program, specially designed for the industry, with special emphasis on small and start-up companies, but any company that has its own labels needs this program! You need my 36 years’ experience as The Vitamin Lawyer and half-century in the nutrient industry!

I can save your company hundreds of thousands of dollars in regulatory costs! Just embrace my three simple steps to regulatory compliance:

[1] PROCEDURE – I work with your CEO to tweak my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company

[2] CLAIMS – I work with your company for proper claims control, definition & substantiation... and the FDA required S&F Claims Notice.

[3] TRAINING - It's not enough to have procedures, says FDA: train your team and prove they are qualified - through my Three Step Program: Presenting, Training, Certifying.

That third step is what this Certification program is designed to accomplish: meeting FDA training requirements.

Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811 The Gold Standard - Vitamin Lawyer Consultancy Certification Program!